EP3151762B1 - Vorrichtung zum abtrennen und entfernen von verkalktem gewebe aus einer herzklappe - Google Patents

Vorrichtung zum abtrennen und entfernen von verkalktem gewebe aus einer herzklappe Download PDF

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Publication number
EP3151762B1
EP3151762B1 EP15733804.7A EP15733804A EP3151762B1 EP 3151762 B1 EP3151762 B1 EP 3151762B1 EP 15733804 A EP15733804 A EP 15733804A EP 3151762 B1 EP3151762 B1 EP 3151762B1
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EP
European Patent Office
Prior art keywords
cutting
tip
cutting member
tissue
valve
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Not-in-force
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EP15733804.7A
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English (en)
French (fr)
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EP3151762A1 (de
Inventor
Bernard Pain
Marco VOLA
Enrico Pasquino
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Pain Bernard
Vola Marco
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Pain Bernard
Vola Marco
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Publication of EP3151762A1 publication Critical patent/EP3151762A1/de
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Publication of EP3151762B1 publication Critical patent/EP3151762B1/de
Not-in-force legal-status Critical Current
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00738—Aspects not otherwise provided for part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22098—Decalcification of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras

Definitions

  • the invention relates to the technical field of endoscopic surgery, and more particularly relates to a device for cutting and removing calcified tissue from the heart valves.
  • the first step consists in decalcifying and removing the parts of the sick valve that can cause para-valvular leakage at the prosthesis to be implanted. It is therefore necessary to cut these diseased and calcified tissues.
  • this operation is performed by means of a chisel, with the obligation to maintain the cut pieces, to prevent them being lost in the blood system.
  • Such an operative gesture is relatively simple in open surgery since there is wide access to the cut ribcage.
  • a device for cutting and evacuating calcified tissue from a heart valve which is remarkable in that it comprises a tubular body adapted to be introduced by minimally invasive means. or endoscopic in relation to a thread guide previously introduced, and able to pass through the flaps of the valve above the part where the calcified tissues must be removed, one of the ends of said body considered at the level of said flaps, presenting a profiled tip of flexible material and arrangements for a lateral overflow of a cutting member of said fabrics, operable with one hand from an outside handle, said arrangements being in communication with suction means and evacuation of cut tissues.
  • the device is not obstructive at the level of the ascending aorta so that this decalcification operation can be performed either in open surgery or in minimally invasive surgery and with positioning, in parallel with the device. optics for use with video assistance or thoracoscopy.
  • the end of the body has, upstream of the arrangements for the lateral overflow of the cutting member, a zone rounded offset laterally to delimit, on the side of the arrangements, a recessed portion and, on the opposite, an overhanging portion adapted to bear with the flaps during the cutting operation under a rotating effect of the body to realize the decalcification of the entire valve.
  • the body is mounted free to rotate relative to the handle being able to be driven manually by means of a wheel.
  • the device has a vision system opening into the recessed portion of the rounded area at the cutting member.
  • the body has a means capable of keeping the vision system in a stable position during the cutting operation.
  • the arrangements for the lateral overflow of the cutting member are constituted by an opening formed at the end of the body, at the tip.
  • the cutting member is shaped to cut the tissues by translation and / or rotation against the edge of the opening, from the center to the periphery of the valve, under a lateral pressure effect.
  • the cutting member has successively active zones of different characteristics, to achieve, first a rough cut, and then a thin section.
  • the device is combined with a washing / aspiration system capable of removing tissue debris and calcification as soon as it is removed, said system being put into operation when the cutting member is actuated and obstructing the opening so to create a seal vis-à-vis the outside.
  • the flexible tip is made in a different color of the area to be decalcified by having a graduation for precise positioning of the working area having the cutting member.
  • the device comprises a tubular body (1) adapted to be introduced minimally or endoscopically, in relation to a wire guide (g), in order to pass through the flaps of the calcified native valve, above the portion where must be removed, calcification.
  • the body (1) can be made of a malleable material to allow the operator to conform to the patient's anatomy.
  • This body (1) is equipped at its end considered level of the shutters of the valve, a profiled tip (2), of flexible material, to pass through the valve and pre-expand the central orifice of the calcified valve to allow the passage of the body (1) and facilitate the positioning of the work area without injuring healthy tissue.
  • the second function of this tip is to limit the lateralization of the ablative part of the device to the aortic ring.
  • the decalcification of the valve proceeds with a removal of the tissues from the central orifice to the periphery, until in contact with the aortic annulus a deep decalcification but without lesions of the tissues of the aortic ring: the plastic tip which is used to cross the valve, once the device is in contact with the aortic ring, is already in support of the tissues of the left ventricular flushing chamber and thus avoids a pressure of the ablative portion of the device can be exercised at the level of the aortic ring.
  • This end equipped with the tip (2) has arrangements for a lateral overflow of a cutting member (3) of said fabrics.
  • this member (3) is operable with one hand from a handle (4) located outside.
  • the body (1) is rotatably mounted relative to the handle (4) being able to be driven manually by means of a knob (5).
  • Arrangements for the lateral overflow of the cutting member (3) consist of an opening (1a) made at the end of the body (1) at the end (2).
  • the end of the body (1) has, upstream of the opening (la) for the lateral overflow of the cutting member (3), a rounded zone (Ib) in continuity with said body (1), but offset laterally with respect thereto.
  • This rounded zone (1b) delimits on the side of the opening (1a), a recessed portion (1b1) and, at the opposite, an overflowing portion (lb2), able to bear with the flaps of the valve during the cutting operation under a rotating effect of the body (1), by means of the wheel (5) , to achieve the decalcification of the entire valve resulting from a circular motion.
  • the tip (2) or the end of the body (1) at said tip is equipped with an adjustable guide means, adapted to cooperate with the calcified tissue, as and when the ablation operation by the cutting system (3), in combination with a spiral path effect applied to said tip (2) or said body.
  • Ablation of the tissue is performed in a spiral path from the center to the periphery of the valve by translational rotation against the edges of the tissue through the cutting system (3).
  • the decalcification is carried out by applying lateral pressure of the cutting system (3) in combination with the guiding means (5) on the calcified tissues.
  • the guiding means is, for example, constituted by a flexible ribbon (8) able to be deployed in a circular manner in the position of contact with the calcified tissues.
  • the ribbon (8) is deployed eccentrically with respect to the end piece (2).
  • the ribbon (8) is mounted in combination, on the one hand with a rotary shaft controlled by an actuator accessible from the outside of the body (1), and, on the other hand, with a part fixed end of the tip (2) from which is deployed said ribbon. More particularly, one of the ends of the ribbon (8) is fixed to the rotary shaft to be wound on the latter and overflow through an opening that has the endpiece (2) or the body (1) to be fixed by its other end to the fixed part of said tip.
  • This fixed part can be constituted by a slot to allow said ribbon to overflow eccentrically.
  • the laterally offset rounded area (1b) of the body (1) is no longer necessary.
  • the cutting member (3) in combination with the rounded area (1b), allows the cutting of the fabric by translation and rotation against the edge of the opening, from the center to the periphery of the valve under a lateral pressure effect.
  • the cutting member (3) can be constituted by a blade, a punch, a milling cutter, an ultrasound system, .... and can successively present several active zones of different characteristics to realize, first of all, a coarse cut, followed by a thin cut or more and more fine cuts.
  • the cutting members (3) at the opening (1a) of the body (1), are in communication with suction means (6) cut tissues. More particularly, the cutting zone is combined with a suction washing system, capable of removing the debris from the calcification tissue as soon as it is removed, in order to prevent the latter, in whole or in part, from ending up in the system. circulatory blood.
  • the system is operated when the cutter (3) is actuated and closes the opening (la) to create a seal against the outside.
  • the tip (2) laterally has an orifice (2a) connected to a suction duct (6a).
  • the device is equipped with a vision system (7) opening into the recessed portion (1b1) of the rounded area (1b) at the cutting member (3).
  • This vision system (7) is of any type known and appropriate and consistent with those commonly used in the field of endoscopic surgery.
  • the figure 5 shows the aortic root (RA) after placement of the wire guide (g), which, in known manner, is engaged to cross the stenotic aortic valve.
  • the device equipped with the vision system (7) is then introduced on the wire guide (g) above the part of the valve where the calcification must be removed ( figure 6 ).
  • the figure 7 shows the device in the engagement position of the tip (2) in the calcified area of the flap.
  • the figures 8 , 9 and 10 show the ablation operation as such, calcified tissues after actuation of the cutting member (3) and rotational drive of the body (1) relative to the handle (4), from the center to the periphery of the valve under a lateral pressure effect. As indicated, each time the cutting device is actuated, the suction washing system is operated.
  • the figure 11 shows the removal of the device after completing the decalcification operation. It is then possible to set up a prosthetic valve by any known and appropriate means.

Claims (12)

  1. Vorrichtung zum Herausschneiden und Entfernen kalzifizierter Gewebe aus einer Herzklappe, wobei sie einen röhrenförmigen Körper (1) umfasst, der dafür geeignet ist, auf minimalinvasivem oder endoskopischem Weg in Verbindung mit einer Fadenführung (g) eingeführt zu werden, welche im Vorfeld eingeführt wurde und dazu befähigt ist, durch die Segel der Klappe zu gelangen, die sich oberhalb des Abschnitts befindet, in welchem kalzifizierte Gewebe entfernt werden müssen, wobei ein Ende des Körpers (1), wenn es auf Höhe der Segel betrachtet wird, ein Profilendstück (2) aus nachgiebigem Material aufweist sowie Aussparungen (1a) für ein seitliches Hervorstehen eines Organs (3) zum Schneiden der Gewebe, welches mit einer Hand ausgehend von einem außengelegenen Griffstück (4) betätigt werden kann, wobei die Aussparungen (1a) mit Mitteln (6) zum Absaugen der geschnittenen Gewebe in Verbindung stehen, dadurch gekennzeichnet, dass das Ende des Körpers (1) vor den Aussparungen (1a) für das seitliche Hervorstehen des Schneideorgans (3) einen abgerundeten, seitlich versetzten Bereich (lb) aufweist, um auf der Seite der Aussparungen (la) einen Hohlabschnitt (1b1) und, auf der gegenüberliegenden Seite, einen hervorstehenden Abschnitt (lb2) abzugrenzen, wobei letzterer dazu befähigt ist, unter Einwirkung der Drehbewegung, in welche der Körper (1) versetzt wird, während des Schneidevorgangs auf den Segeln aufzuliegen, um die gesamte Klappe zu entkalzifizieren.
  2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass das Endstück (2), oder das Ende des Körpers (1) auf Höhe der Verbindung mit diesem Endstück, mit einem einstellbaren Führungsmittel versehen ist, das dazu befähigt ist, in Kombination mit einer spiralförmigen Wegstrecke, gemäß welcher das Endstück zur Anwendung gebracht wird, im Laufe des Vorgangs des Abschälens durch das Schneidesystem (3) mit den kalzifizierten Geweben zusammenzuwirken.
  3. Vorrichtung nach Anspruch 2, dadurch gekennzeichnet, dass es sich bei dem einstellbaren Führungsmittel um ein nachgiebiges Band handelt, das dazu befähigt ist, kreisend und exzentriert derart positioniert zu werden, dass es sich mit den kalzifizierten Geweben in Kontakt befindet.
  4. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass der Körper (1) frei drehbar gegenüber dem Griffstück (4) angebracht ist, wobei er dazu befähigt ist, mittels eines Stellrads (5) von Hand angetrieben zu werden.
  5. Vorrichtung nach einem beliebigen der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass sie ein Sichtsystem (7) auf Höhe des Schneideorgans (3) aufweist.
  6. Vorrichtung nach einem beliebigen der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass der Körper ein Mittel (1) aufweist, das dazu befähigt ist, das Sichtsystem (7) während des Schneidevorgangs in stabiler Position zu halten.
  7. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass die Aussparungen für das seitliche Hervorstehen des Schneideorgans (3) aus einer Öffnung (1a) bestehen, die am Ende des Körpers auf Höhe des Endstücks (2) ausgebildet ist.
  8. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass das Schneideorgan (3) derart ausgestaltet ist, dass die Gewebe durch eine Translations- und/oder Drehbewegung gegen den Rand der Öffnung herausgeschnitten werden, ausgehend von der Mitte bis zum Randbereich der Klappe, unter Einwirkung eines seitlichen Drucks.
  9. Vorrichtung nach Anspruch 8, dadurch gekennzeichnet, dass das Schneideorgan (3) nacheinander Wirkbereiche mit verschiedenen Eigenschaften aufweist, um zunächst einen groben Schnitt und dann einen oder mehrere feine(n) Schnitt(e) durchzuführen.
  10. Vorrichtung nach einem beliebigen der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass sie mit einem System zum Waschen/Absaugen kombiniert ist, welches dazu befähigt ist, Gewebe- und Kalzifizierungsbruchstücke zu entfernen, sobald diese abgeschält wurden, wobei das System in Betrieb gesetzt wird, wenn das Schneideorgan (3) betätigt wird, und es die Öffnung verschließt, um eine Abdichtung nach außen hin zu bewirken.
  11. Vorrichtung nach Anspruch 10, dadurch gekennzeichnet, dass das Endstück (2) seitlich eine Öffnung aufweist, die mit einer Saugleitung in Verbindung steht.
  12. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass das nachgiebige Endstück (2) derart hergestellt ist, dass es eine andere Farbe als der zu entkalzifizierende Bereich hat, und mit einer Messeinteilung versehen ist, um den Arbeitsbereich, welcher das Schneideorgan (3) aufweist, genau zu positionieren.
EP15733804.7A 2014-06-05 2015-06-04 Vorrichtung zum abtrennen und entfernen von verkalktem gewebe aus einer herzklappe Not-in-force EP3151762B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1455145A FR3021859A1 (fr) 2014-06-05 2014-06-05 Dispositif de decoupe et d'evacuation de tissus calcifies d'une valve cardiaque
PCT/FR2015/051490 WO2015185871A1 (fr) 2014-06-05 2015-06-04 Dispositif de decoupe et d'evacuation de tissus calcifies d'une valve cardiaque

Publications (2)

Publication Number Publication Date
EP3151762A1 EP3151762A1 (de) 2017-04-12
EP3151762B1 true EP3151762B1 (de) 2018-02-14

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Country Link
US (1) US20170151009A1 (de)
EP (1) EP3151762B1 (de)
JP (1) JP2017516635A (de)
CN (1) CN106659519A (de)
AU (1) AU2015270257A1 (de)
BR (1) BR112016028516A2 (de)
ES (1) ES2661590T3 (de)
FR (1) FR3021859A1 (de)
IL (1) IL249377A0 (de)
SA (1) SA516380433B1 (de)
WO (1) WO2015185871A1 (de)

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CN115774310B (zh) * 2023-02-10 2023-04-25 成都亨通光通信有限公司 一种层绞式光缆

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Publication number Publication date
JP2017516635A (ja) 2017-06-22
FR3021859A1 (fr) 2015-12-11
EP3151762A1 (de) 2017-04-12
SA516380433B1 (ar) 2018-05-29
CN106659519A (zh) 2017-05-10
US20170151009A1 (en) 2017-06-01
IL249377A0 (en) 2017-02-28
AU2015270257A1 (en) 2016-12-22
ES2661590T3 (es) 2018-04-02
WO2015185871A1 (fr) 2015-12-10
BR112016028516A2 (pt) 2017-08-22

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